Senior Supplier Quality Engineer

Coloplast; Minneapolis (MN); Hybrid; USD 116,000 - 174,000; Full time

Benefits offered by this job

Health and Wellness

401(k) plan with company match

Work-life balance

Professional development and tuition

Recognition programs

Community and culture

Competitive compensation

Job summary

Coloplast in Minneapolis is seeking an Interventional Urology Sr. Supplier Quality Engineer to strengthen its supplier management program and ensure quality across finished goods, intermediates, and raw materials.

You will lead supplier audits, drive quality improvements, manage supplier agreements, and support validation, CAPA, and risk management activities with up to 10% travel.

Qualifications

• Bachelor's degree in a relevant science or engineering discipline.
• 5+ years of related experience in supplier management.
• 2+ years of experience in medical device manufacturing.
• Experience in medical device process and product validation, sampling, and statistics (DOE, process analysis/capability, Minitab, and repeatability and reproducibility) highly preferred.
• Able to travel up to 10%.

Responsibilities

• Provide direct quality engineering support and strategic solutions to the supply chain to ensure quality compliance, FDA/ISO compliance and issue resolution; act as the supplier quality SME in appropriate projects.
• Manage the Supplier Quality Audit program; includes performing audits or coordinating an outside firm to perform the audits, maintain the Supplier Quality Audit schedule and audit-related records/documents.
• Act as internal interface/liaison and partner to Corporate Procurement.
• Active participation in Material Review Board meetings.
• Initiate and update Supplier Quality Agreements.
• Recommend and implement quality improvements of product and processes to promote continuous improvement at suppliers and contract manufacturers.
• Initiate supplier investigation requests and assist in root cause investigations for supplier related issues.
• Participate in product and process risk management activities.
• Participate in Corrective and Preventive Actions as appropriate.
• Review and approve validation protocols and reports for contract manufacturers and suppliers.
• Initiate Change Requests to update documentation and Supplier Change Notifications.
• Cross-training with others in the Quality Team.
• Other duties as assigned.

Skills

FDA regulations knowledge

ISO standards knowledge

Lean six-sigma

Auditing experience

Lead Auditor Certification

Minitab

DOE

Process capability

Analytical problem-solving

Supplier scorecards

Travel up to 10%

Education

Bachelor's degree in science or engineering

Job description

The Interventional Urology Sr. Supplier Quality Engineer will support our ongoing supplier base and actively participate in our supplier management program. You will also be responsible for supporting quality deliverables for projects related to suppliers of finished goods, intermediates, and raw materials. In addition, you will monitor and maintain quality compliance and implement supplier improvements. In all actions, demonstrate a primary commitment to patient safety and product quality.

Major Areas of Accountability

• Provide direct quality engineering support and strategic solutions to the supply chain to ensure quality compliance, FDA/ISO compliance and issue resolution; act as the supplier quality subject matter expert (SME) in appropriate projects.
• Manage the Supplier Quality Audit program; includes performing audits or coordinating an outside firm to perform the audits, maintain the Supplier Quality Audit schedule and audit-related records/documents.
• Act as internal interface/liaison and partner to Corporate Procurement.
• Active participation in Material Review Board meetings.
• Initiate and update Supplier Quality Agreements.
• Recommend and implement quality improvements of product and processes to promote continuous improvement at suppliers and contract manufacturers.
• Initiate supplier investigation requests and assist in root cause investigations for supplier related issues.
• Participate in product and process risk management activities.
• Participate in Corrective and Preventive Actions as appropriate.
• Review and approve validation protocols and reports for contract manufacturers and suppliers.
• Initiate Change Requests to update documentation and Supplier Change Notifications.
• Cross-training with others in the Quality Team.
• Other duties as assigned.

Basic Qualifications

• Bachelor's degree in a relevant science or engineering discipline.
• 5+ year of related experience in supplier management.
• 2+ years of experience in medical device manufacturing.
• Experience in medical device process and product validation, sampling, and statistics (e.g. DOE, process analysis/capability, Minitab, and repeatability and reproducibility) highly preferred.
• Able to travel up to 10%.

Required Knowledge, Skills and Abilities

• Knowledge of FDA regulations (21 CFR Part 820) and ISO standards (13485, 14971) and their application.
• Ability to apply standard techniques, procedures, and criteria to perform assigned tasks.
• Exercises judgment on details of work and able to demonstrate knowledge and developing skills in the supplier quality function.
• Analytical problem-solving skills.
• Experience with continuous improvement, Lean six-sigma, or similar programs and techniques.
• Familiarity with Supplier Scorecards and Management techniques highly preferred.
• Prior experience as an auditor for both suppliers and internal audits highly preferred
• Lead Auditor Certification highly preferred
• Personifies and fosters the Coloplast Mission, Vision and Values.

At Coloplast, we believe in recognizing and rewarding the contributions of our employees. Our total rewards package is designed to support your well-being, foster your professional growth, and ensure a healthy work-life balance. Here is some of what you can expect:

• Health and Wellness : Comprehensive medical, dental, and vision insurance plans to keep you and your family healthy. Plus, access to company sponsored wellness programs and mental health resources, paid leave of absence for qualifying events and generous paid parental leave for both birthing and non-birthing parents.
• Financial Security: A competitive 401(k) plan with company match that vest immediately, financial planning services to help you secure your future, and corporate discount programs for goods and services.
• Work-Life Balance: Generous paid time off, flexible work hours, and flexible work arrangement options to help you balance your personal and professional life may be available.
• Professional Development: Opportunities for continuous learning and career advancement through training programs, mentorship, and tuition reimbursement.
• Recognition and Rewards: Recognition programs to celebrate achievements and contributions, including peer recognition, bonuses, awards, and special events.
• Community and Culture: A supportive work environment where everyone feels valued, and has a sense of belonging. Participate in team-building activities, volunteer opportunities, and company-sponsored events. Sustainability strategy that outlines our ambitions for how to run our company in a more sustainable way.
• Competitive Compensation : The compensation range for this position is $115,876 - $173,813. Actual compensation is influenced by a variety of factors including but not limited to skills, experience, qualifications, and geographic location. Hired candidates may be eligible to receive additional compensation in the form of bonuses and/or incentives.

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 16,000 people and with products available in more than 143 countries, we are one of the world leading medical device companies. We are constantly growing our business and always looking for new ways to move forward we explore, learn and look for new ways of doing things.

Coloplast employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the Advamed Code of Ethics on Interactions with Healthcare Professionals, and company policies.

Coloplast is committed to a policy of Equal Employment Opportunity (EEO) which means we employ and promote individuals based on their merits, regardless of race, color, religion, sex, national origin, age, disability, veteran status, pregnancy, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, status with regards to public assistance or any other protected classification.

Coloplast Group - Holtedam 1 - Humlebaek - DK 3050 - Denmark